A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Merrimack Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01733004
First received: November 20, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3" design, evaluating MM-141 at varying dose levels and frequencies.


Condition Intervention Phase
Advanced Solid Tumors
Drug: MM-141
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Severity and number of adverse events related to escalating doses of MM-141 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.


Estimated Enrollment: 45
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
MM-141 monotherapy
Drug: MM-141
Experimental: Arm B
MM-141 and Everolimus
Drug: MM-141
Experimental: Arm C
MM-141 and Abraxane and Gemcitabine
Drug: MM-141

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy
  • Eighteen years of age or above
  • Able to understand and sign an informed consent (or have a legal representative who is able to do so)
  • Measurable disease according to RECIST v1.1
  • ECOG Performance Score of 0 or 1
  • Adequate bone marrow, hepatic, renal and cardiac function
  • Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141

Exclusion Criteria:

  • Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing
  • Symptomatic CNS disease
  • Received other recent antitumor therapy
  • Pregnant or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733004

Contacts
Contact: Akos Czibere, MD, PhD 617-441-1000

Locations
United States, Georgia
Georgia Cancer Specialists Recruiting
Marietta, Georgia, United States
Contact: Christopher Moore, RHIT, CTR    770-496-9427    christopher.moore@gacancer.com   
Principal Investigator: Mansoor Saleh, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Contact: Steven Isakoff, MD, PhD    617-726-2000      
Principal Investigator: Steven Isakoff, MD, PhD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States
Contact: Karen Forman, BAA, CCRP    313-576-8096    formank@karmanos.org   
Principal Investigator: Patricia LoRusso, DO         
France
Institut Goustave Roussy Recruiting
Villejuif, France
Contact: Monica Arnedos, MD    0033 1 42 11 40 68    monica.arnedos@igr.fr   
Principal Investigator: Jean-Charles Soria, Pr         
Sponsors and Collaborators
Merrimack Pharmaceuticals
  More Information

No publications provided

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01733004     History of Changes
Other Study ID Numbers: MM-141-01-01-01
Study First Received: November 20, 2012
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Merrimack Pharmaceuticals:
Cancer
Solid tumors
Oncology
Phase I
ErbB3
IGF-1R
Everolimus
Gemcitabine
Abraxane

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014